SafetyTector™ S Cat. No. #400 ONLY for OEM
SafetyTector™
SafetyTector™ S is a SARS-CoV-2 inactivating extraction and dilution buffer for saliva specimens and nasopharyngeal swabs. Swabs can be extracted directly with SafetyTector™ S.
SafetyTector™ S eliminates the high risk of infection during and after testing coming from the specimen or other test materials. Virus inactivation was confirmed and tested with infectious viruses in a Biosafety Level 3 laboratory.
SafetyTector™ S completely eliminates infectivity of SARS-CoV-2
Samples diluted in SafetyTector™ S can directly be used in lateral flow assays and also in other immunoassays such as ELISA, protein arrays oder bead-based assays.
In tests with commercially available SARS-CoV-2 antigen rapid tests, SafetyTector™ S shows comparable or better performance than supplied extraction and dilution buffers. In some cases, further improvement in the detection limit was observed.
The suitability of SafetyTector™ S for the respective assay has to be tested by the manufacturer or distributor.
When and how to use SafetyTector™ S?
Safe Design of in vitro diagnostic medical devices (IVD products) is an obligatory pre-requisite for placing them on the international markets in the EU. This is defined in EU legislation (Directive 98/79/EG, Annex I, chapter B, clause 2.1 and Regulation (EU) 2017/746, Annex I, Chapter I, clause 4). Besides that, the ISO 14971 „application of risk management to medical devices“ (ISO 14971:2012, Annex A, chapter A.2.6 risk control) - decisive for the correct implementation of the ISO 13485 - mandates a risk control procedure and thus gives another regulatory binding basis for ensuring that IVDs are safe and secure for the user in all international markets. Safe Design includes that the risk of infection for the user is eliminated or reduced to the lowest possible level – this is especially important for IVDs for highly infectious viruses such as SARS-CoV-2. The current pandemic situation with the highly infectious variants of SARS-CoV-2 forces immediate action even for IVD products already on the market.
Virus-inactivating extraction buffers are an easy-to-use and effective tool to produce IVDs in conformity with these mandatory regulations.
During the past there were no virus-inactivating extraction buffers, proven to be able to inactivate SARS-CoV-2 by experiments under real conditions with infective viruses, available on the market.
SafetyTector™ S thus sets a current state of the art in terms of safe design for user safety during antibody- and antigen-tests – especially in rapid lateral flow testing. Testing virus inactivation with substitute test materials such as virus-like particles (VLPs) cannot safely allow the same conclusions in terms of user safety.
Together with SafetyTector™ S, manufacturers of IVD directly get the necessary evidence for virus inactivation in form of a “Letter of Acknowledgement” from the testing Biosafety Level 3 laboratory.
Download Product Resources
SARS-CoV-2 antigen tests: safety for less than 5 cents per test
Product Descriptions & Guides
Product Inserts and Data Sheets
Brand | CANDOR Bioscience |
Code | 400 902 |
Product Flyers and Application Guides
Assay Optimizers
Assay Defender® Cat. No. #180
LowCross-Buffer® Cat. No. #100
LowCross-Buffer® Cat. No. #101, #102
LowCross-Buffer® Animal-free/Protein-free Cat. No. #300
Low-Cross-HRP® Cat. No. #200
LowCross® HRP-Stab Cat. No. #270
LowCross® HRP-Stab Animal-free/Protein-free Cat. No. #370
Sample Buffer Cat. No. #105, #106
Sample Buffer Animal-free/Protein-free Cat. No. #305
Covid-19 Inactivation and Dilution Buffer
SafetyTector™ S Cat. No. #400
Blockers
The Blocking Solution Cat. No. #110
BSA-Block Cat. No. #115
PlateBlock™ Cat. No. #112
SmartBlock™ Cat. No. #113
Stabilizers
Antibody Stabilizer TRIS Cat. No. #130
Antibody Stabilizer TRIS Animal-free/Protein-free Cat. No. #330
Antibody Stabilizer PBS Cat. No. #131
Antibody Stabilizer PBS Animal-free/Protein-free Cat. No. #331
AP-Protector® Cat. No. #235
Liquid Plate Sealer® Cat. No. #160
Liquid Plate Sealer® Animal-free Cat. No. #163
HRP-Protector™ Cat. No. #222
HRP-Protector™ Animal-free/Protein-free Cat. No. #322
Standard Buffers (ready-made)
Coating Buffer pH 7.4 Cat. No. #120
Coating Buffer pH 9.6 Cat. No. #121
Stripping Buffer Cat. No. #150
Washing Buffer PBS Cat. No. #140
Washing Buffer PBS IHC Cat. No. #141
Washing Buffer TRIS Cat. No. #145
Washing Buffer TRIS IHC Cat. No. #146
Publications
CoViD-19-antibody-test-challenge
Interference and HAMA problems
IVD technology article
Long-term stabilization of assay components
Optimisation of assays: Interference in immunoassays recognize and avoid
SARS-CoV-2 antigen tests: safety for less than 5 cents per test
Specificity, positive predictive value and validation statistics in the context of CoViD-19
The appropriate blocker — A short overview
The right strategy saves much costs